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Fact or Fiction: Legal Restrictions to Patient Engagement in Drug Development

Oct 14 2014 11:00AM - Oct 14 2014 12:30PM | Online

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Overview 

This webinar will be broadcast in Eastern Time (ET)



Drug companies stress the importance of engaging patients not only earlier, but also throughout the drug development process. However, this desire is frequently tempered by the perception, or misperception, that the body of legal and regulatory considerations blocks them from implementing and involving the patient voice. This webinar will clarify the laws and regulations addressing hot topics such as involving patients in clinical trial design, social media, patient recruitment and retention, disclosure of information to clinical trial participants, contacting specific patient advocacy organizations, and direct to consumer advertising. Panel members will offer practical advice and solutions to secure greater patient involvement.

Who Should Attend 

Individuals in working in the following areas:

  • Advisory Committees
  • Attorneys
  • Clinical Trials
  • CROs
  • FDA
  • INDs
  • Informed Consent
  • IRBs
  • Legal
  • Patient Advocacy
  • Patient Engagement
  • Regulatory

Learning Objectives 

At the conclusion of this webinar, participants should be able to:

  • Identify the regulatory considerations and legal parameters of patient engagement in drug development
  • Explain the nature and scope of information disclosure to participants in clinical trials
  • Discuss solutions to legal implications of hot topics such as patient involvement in clinical trial design, social media, off label use, and direct advertising

Contact Information 

Printable Registration Form

Registration Questions and Technical Support Day of Event
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

For more information
Carrie Dunn, Content Lead
Phone +1.215.442.6181
Fax +1.215.442.6199
Carrie.Dunn@diahome.org

 

Technical Requirements 

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Technical Support Day of Event
Toll Free 1.888.257.6457
Phone +1.215.442.6100
Fax +1.215.442.6199
Monday-Friday 8:30AM-8:00PM ET
CustomerService@diahome.org

Presenter(s) 

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Continuing Education 

The Drug Information Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. The Drug Information Association designates this educational activity for up to1.5 contact hours or .15 continuing education units (CEUs).
0286-0000-14-083-L04-P; Type of Activity: Knowledge

ACPE Credit Request – UPDATE
DIA is required by the Accreditation Council for Pharmacy Education (ACPE) to report pharmacy-requested CEUs through the CPE Monitor system. All ACPE-certified activity credit requests need to be submitted through DIA’s My Transcript within 45-days post activity. Pharmacists will need to provide their National Association of Boards of Pharmacy (NABP) e-Profile ID and date of birth (MMDD) to ensure the data is submitted to the ACPE and NABP properly. If you need to obtain your NABP e-Profile, please visit www.cpemonitor.net.

The Drug Information Association has been accredited as an Authorized Provider by the International Association for Continuing Education and Training (IACET).

As an IACET Authorized Provider, Drug Information Association offers CEUs for its programs that qualify under the ANSI/IACET Standard. Drug Information Association is authorized by IACET to offer .2 CEUs for this program. Participants must attend the entire program in order to be able to receive an IACET statement of credit. No partial credit will be awarded.

DIA’s Certificate Program Statement
This program is part of DIA’s Certificate Program and is awarded the following:
• Regulatory Affairs Certificate Program: X Elective Units

For more information go to www.diahome.org/certificateprograms

Name Credit Type Max Credits CEU
Fact or Fiction: Legal Restrictions ACPE 1.50 0.150
Fact or Fiction: Legal Restrictions IACET 1.50 0.200

Disclosure Policy:

It is DIA policy that anyone in a position to control the content of a continuing education activity must disclose to the program audience (1) any real or apparent conflict(s) of interest related to the content of their presentation and/or the educational activity, and (2) discussions of unlabeled or unapproved uses of drugs or medical devices. Disclosure statements will be included in the course materials.

Statement of Credit:

If you would like to receive a statement of credit, you must participate in the live webinar, and complete the credit request process through My Transcript. To access My Transcript, please go to www.diahome.org, select “Login to My DIA” and you will be prompted for your user ID and password. Select “My Transcript” (left side bar) and “Credit Request” to process your credit request. Participants will be able to download a statement of credit upon successful submission of the credit request. My Transcript will be available for credit requests on Tuesday, October 28, 2014.

Continuing education credits are available to learners who participate in the live webinar. Continuing education credits are not available for participation in the archived version of the webinar.

Registration Fees 

Other Fees

Group Site
$799.00
Group Plus
$1499.00

Member

Member Government Individual
$125.00
Charitable Nonprofit/Academia Member Individual
$175.00
Member Individual
$250.00

Non-Member

NonMember Government Individual
$125.00
Charitable Nonprofit/Academia Nonmember Individual
$175.00
NonMember Individual
$350.00
Registration Information

Printable Registration Form

  • Individual registration is a license for ONE internet login allowing one viewer.
  • Group site registration is a license for ONE internet login allowing multiple viewers from one location.
  • Group Plus is a license for up to FIVE internet logins allowing one or more viewers at each login location.


Cancellations:  No refunds will be provided in the event of a participant’s cancellation since all costs for this webinar have been prepaid by DIA. DIA reserves the right to modify or cancel programs and/or substitute presenters or panelists. DIA is not responsible for failure to deliver programs due to circumstances beyond its control.

Participants with Disabilities: Reasonable accommodations will be made available to persons with disabilities who attend an educational activity. Contact the DIA office in writing at least 15 days prior to event to indicate your needs.

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Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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